15 results
·
18ms
·
Sources: EU EUDAMED, US FDA
LDC CONSTAMETRIC III HIGHT PRESS. SOL.
FDA 510(k)
FDA Class 1
·Clinical Chemistry
BaseVac
FDA UDI
R. E. Morrison Equipment Inc·D13028000480·2SUR4.16-1 | 6 User Dual Surgical Vacuum | NFPA...
NAR Kit
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209100385·KIT, CCR-MEDIC LEG RIG - COY; This kit contains...
ACUMED
FDA UDI
Acumed LLC·10806378039546·Radiolucent VDR Tgt Guide Wide, R
LOSPA IS Spinal Fixation System
FDA UDI
Corentec Co., Ltd·08800017278551·Spinal Instrument - Table top rod cutter
Pilot Spinal System
FDA UDI
Life Spine, Inc.·00190837008932·
ORTHO ARCH
FDA UDI
Ortho Arch Company Inc·D9098000481·HEAVY BAND PUSHER
KETAC-CEM IN REF. TO K802048
FDA 510(k)
FDA Class 2
·Dental
SEALOUETTE FIBRIN SEALANT EXTENDED DROPLET APPLICATOR, MODEL TE-1
FDA 510(k)
FDA Class 2
·General Hospital
MSK EXTREME MR SCANNER, MODEL AA5000
FDA 510(k)
FDA Class 2
·Radiology
FLANGE FIXTURE AND ABUTMENT
FDA Adverse Event
Injury
·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·May 8, 2014
MERIT CUSTOM KIT
FDA Adverse Event
Malfunction
·MERIT MEDICAL SYSTEMS, INC.·Product code FMF·October 17, 2012
MANUAL ORTHOPEDIC SURGICAL INSTRUMENT
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK·Product code HXX·August 11, 2010
Model: CT 5300; Product Code (REF): 728285; Software Versions: 5.1.0.X & 5.1.1.X;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS·November 5, 2025
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012